Icatibant Injection (Jamp Pharma): Uses, Side Effects and Dosage

What is Icatibant Injection used for?

Icatibant Injection is used to treat acute attacks of hereditary angioedema (HAE). It is used in adults and children aged 2 years and older, with a deficiency of a protein called C1-esterase inhibitor.

How does Icatibant Injection work?

In HAE, levels of a substance in your bloodstream called bradykinin are increased. This can cause swelling, pain, nausea, and diarrhea. Icatibant Injection blocks the activity of bradykinin. This stops the symptoms of a HAE attack from getting worse.

What are the ingredients in Icatibant Injection?

Medicinal ingredient: Icatibant (as icatibant acetate)

Non-medicinal ingredients: Glacial acetic acid, sodium chloride, sodium hydroxide and water for injection.

Icatibant Injection comes in the following dosage forms:

Solution for injection, 30 mg / 3 mL (10 mg / mL)

Do not use Icatibant Injection if:

• you are allergic to icatibant acetate or to any ingredient in this medicine.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you use Icatibant Injection. Talk about any health conditions or problems you may have, including if you:

• have heart problems such as unstable angina (reduced blood flow to the heart muscle).
• have recently suffered a stroke.
• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed.

Other warnings you should know about:

Only a doctor who has experience treating patients with HAE is recommended to treat you with Icatibant Injection.

Caregivers / Self-administration:

• Your first injection of Icatibant Injection should be given under the guidance of a healthcare professional. Your healthcare professional will tell you when it is safe to go home.
• You or your caregiver may inject Icatibant Injection only after receiving training on how to use it. A healthcare professional will teach you how to use it.
• Self-injection for children is not recommended. Icatibant Injection should only be given to children by a healthcare professional or caregiver.
• Adolescents may only self-inject if their doctor and caregiver agree that it is appropriate for them to do so.

Laryngeal HAE attacks:

• A laryngeal HAE attack, or an attack of the throat, can become life-threatening. This is because increased swelling of the throat can create a blockage of the upper airway. This in turn makes breathing difficult.

• If you have a laryngeal HAE attack:

  • inject Icatibant Injection, and
  • go to the nearest hospital emergency room for medical help right away.
• A blockage of the airway may occur faster in children and adolescents than in adults. This is because the airway passage is smaller in these patients.

Adolescents and Children:

• Icatibant Injection is not recommended for use in children under 2 years of age or those who weigh less than 12 kg

• There is limited experience with the use of Icatibant Injection in the treatment of:

  • children under 6 years of age
  • laryngeal HAE attacks in adolescents and children

Effects on Reproductive Organs in Adolescents and Children aged 2 years and above:

• The effects of long-term Icatibant Injection use are not known.
• Early studies have shown that when Icatibant Injection is used often, it may cause damage to the reproductive system or may affect how it develops.

• Your healthcare professional may do blood tests to check how your or your child’s reproductive

  organs are working.

Pregnancy and Breastfeeding:

• It is not known if Icatibant Injection will harm your unborn baby. If you are pregnant or planning to become pregnant, speak to your healthcare professional before using Icatibant Injection. You and your healthcare professional will decide if Icatibant Injection is right for you.
• It is not known if Icatibant Injection passes into breast milk. If you are breastfeeding or planning to breastfeed, speak to your healthcare professional before using Icatibant Injection about the best way to feed your baby.

Driving and Using Machinery

• Icatibant Injection may cause tiredness, dizziness or sleepiness. DO NOT drive or operate machinery after using Icatibant Injection if you feel tired or dizzy.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Icatibant Injection:

• Angiotensin converting enzyme (ACE) inhibitor (used to lower blood pressure).

How to use Icatibant Injection:

• You may inject Icatibant Injection only after receiving training on how to use it.
• Always use Icatibant Injection exactly as your healthcare professional has shown you.
• Be sure to use each Icatibant Injection prefilled syringe only once, even if there is still medicine in it.
• Icatibant Injection is given as a single injection under the skin on the stomach. This is called a subcutaneous injection.

• In adults and adolescents who weigh more than 65 kg:

  • The Icatibant Injection prefilled syringe will be used to give the injection.

• In adolescents who weigh 65 kg or less and children aged 2 years and above:

  • Some Icatibant Injection will need to be transferred from the prefilled syringe into an empty graduated syringe. This graduated syringe will then be used to inject Icatibant Injection.

Read and follow the below STEP-BY-STEP INSTRUCTIONS FOR INJECTION. It will take you through the process to inject Icatibant Injection.

The solution should be clear and colourless and free from visible particles. Do not use this medication if it looks cloudy or is leaking. Prefilled syringes are for single-use only.

Usual dose:

All Patients:

• Use Icatibant Injection as soon as you have symptoms of a HAE attack. Symptoms can include swelling, pain, nausea, and diarrhea.
• If you have a laryngeal HAE attack, inject Icatibant Injection and then go to the nearest hospital emergency room for medical help right away.

Adults:

• The recommended dose is 3 mL. Use the full contents of the Icatibant Injection prefilled syringe.
• If the symptoms continue, worsen, or come back, and it has been at least 6 hours from the first injection: give another injection.
• Do not use more than 3 injections in 24 hours. Talk with your healthcare professional before using more than 8 doses per month.

Adolescents (weighing more than 65 kg):

• The recommended dose is 3 mL. Use the full contents of the Icatibant Injection prefilled syringe.
• If the symptoms continue, worsen, or come back, seek immediate medical advice. Do not use more than 1 injection for a single HAE attack.

Adolescents (weighing 65 kg or less) and Children (aged 2 and above):

• The recommended dose is between 1 mL to 2.5 mL. The dose is based on body weight.
• You will need to use only some of the Icatibant Injection prefilled syringe.
• See the below STEP-BY-STEP INSTRUCTIONS FOR INJECTION for the dose to inject. If you are not sure, speak to your healthcare professional.
• The dose may change from one injection to the next with changes in body weight.
• If the symptoms continue, worsen, or come back seek immediate medical advice. Do not use more than 1 injection for a single HAE attack.

STEP-BY-STEP INSTRUCTIONS FOR INJECTION:

This section contains information on how to give an injection of Icatibant Injection.

Read these instructions before using Icatibant Injection and each time you get a repeat prescription. There may be new information.

These instructions are not meant to take the place of training by a healthcare professional. A healthcare professional will teach you and your caregiver how to give Icatibant Injection. Ask your healthcare professional any questions you may have. Do NOT attempt to inject Icatibant Injection until you are sure how to and your doctor has determined that it is appropriate for you to do so.

JAMP Care Patient Support Program has been set up to provide guidance and additional training on how to use Icatibant Injection. It will give you information and answer any questions you may have. Icatibant Injection and supplies needed to give it are provided through this Program. Information including training can be obtained through the Program by calling JAMP at 1-866-399-9091.

Step 1 – Gather supplies

ALL PATIENTS Adults, Adolescents and Children (Aged 2 years and above)

Collect the following listed items to prepare and give the injection: Items provided to you with your Icatibant Injection prescription: 1) Your Icatibant Injection carton, which includes: One single-use prefilled syringe (containing 3 mL of Icatibant Injection solution). One capped needle. 2) The administration supplies, which include(s): One alcohol wipe. For Adolescents (weighing 65 kg or less) and Children (Aged 2 years and above), The following supplies are needed to measure out and transfer the dose: One 3 mL graduated syringe. One connector. Not provided with Icatibant Injection: 3) A sharps disposal container. If you do not have a sharps disposal container, you may use a household container that is: Made of heavy-duty plastic or metal. An empty detergent bottle or coffee can may be used. Properly labelled. Using a marker, write “BIOHAZARD” on the container.

B) Transferring Icatibant Injection to the Empty Graduated Syringe

If you are not sure of how much solution to draw up, ask your healthcare professional.

Dosing for Adolescents and Children:

• Continue to push on the plunger of the prefilled syringe. Do this until the required injection volume (dose) is transferred to the graduated syringe. Use the markings on the graduated syringe to measure the dose.
• If there is Air in the Graduated Syringe:
• Turn the connected syringes so that the prefilled syringe is on top.
• Push the plunger of the graduated syringe to transfer any air back into the prefilled syringe.
• Pull gently on the plunger of the graduated syringe. Do this until the required injection volume is transferred to the graduated syringe. Use the marking on the graduated syringe to measure the dose.
• You may need to repeat these actions several times.

1. D)

   Disconnect the Graduated Syringe:

   • Remove the Icatibant Injection prefilled syringe and connector from the graduated syringe.
   • Put down the graduated syringe on the clean work surface.

   • Discard the Icatibant Injection prefilled syringe and connector into a sharps disposal container.

     Be sure to use each Icatibant Injection prefilled syringe only once. Reuse may lead to infection or other illness / injury.

Step 4 – Preparing the syringe and needle for injection		ALL PATIENTS Adults, Adolescents and Children (Aged 2 years and above)
		Remove the seal from the needle cap. Keep the needle inside the protective needle cap until ready to use.
		Grip the syringe firmly. For adults and adolescents weighing more than 65 kg: The syringe is the Icatibant Injection prefilled syringe. For adolescents weighing less than 65 kg and children: The syringe is the graduated syringe. Carefully attach the needle to the prefilled syringe. Firmly screw the needle on the syringe containing the Icatibant Injection dose. Be careful not to remove the needle from the needle cap.

Step 5 – Preparing the injection site	ALL PATIENTS Adults, Adolescents and Children (Aged 2 years and above)
Choose the injection site. The injection site should be a fold of skin on the stomach, about 5 to 10 centimetres (2 to 4 inches) below the belly button on either side. The area you choose for injection should be at least 5 centimetres (2 inches) away from any scars. Do NOT choose an area that is bruised, swollen, or painful.
Clean the Icatibant Injection injection site with an alcohol wipe and allow it to dry.

Step 6 – Injecting Icatibant Injection

ALL PATIENTS Adults, Adolescents and Children (Aged 2 years and above)

Remove the needle from the needle cap by holding the needle cap and carefully pulling the syringe. Do NOT pull up on the plunger. Hold the syringe in one hand, between your fingers and thumb. Use your other hand to gently pinch the fold of skin you cleaned with the alcohol wipe between your thumb and fingers for your injection. Hold the syringe between a 45 to 90 degree angle to the skin with the needle facing the fold of skin you are holding.

• Hold the fold of skin. Bring the syringe to the skin and quickly insert the needle into the skin fold.

• Slowly push the plunger at the top of the syringe over at least 30 seconds. Continue to push the plunger until no Icatibant Injection is left in the syringe.

• Release the skin fold and gently pull the needle out.

Overdose:

Missed dose:

Not applicable.

If you think you, or a person you are caring for, have taken too much Icatibant Injection, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs.

What are possible side effects from using Icatibant Injection?

These are not all the possible side effects you may have when taking Icatibant Injection. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• burning, redness, swelling, pain, itching, or warmth at the injection site
• abdominal pain or distension
• diarrhea
• nausea
• fever
• upper respiratory tract infection (common cold)
• inflammation of the sinuses
• nasal congestion
• dizziness
• headache
• worsening or recurrence of HAE
• rash
• hives
• dry mouth
• fatigue

Icatibant Injection may affect certain liver enzyme levels in your blood. Your healthcare professional will decide when to perform blood tests and will interpret the results.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Storage:

• Store at 15-30°C.
• Do not freeze.
• Store Icatibant Injection in the original carton until you are ready to use it.
• Keep out of reach and sight of children.

If you want more information about Icatibant Injection:

• Talk to your healthcare professional.
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), or by calling 1-866-399-9091.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

• For information about JAMP Care Patient Support Program, contact JAMP at 1-866-399-9091.

JAMP Pharma Corporation

1310 rue Nobel

Boucherville, Québec

J4B 5H3, Canada

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